Xeris Pharmaceuticals Announces FDA Acceptance for Review of NDA for Its Ready-to-Use Glucagon Rescue Pen
If approved, the Xeris glucagon rescue pen would be the first ready-to-use, room-temperature stable liquid glucagon in an auto-injector to treat severe hypoglycemia
Robust clinical trial results from multiple Phase 3 studies and Human Factors studies demonstrating safety and efficacy in emergency settings support the NDA
PDUFA goal date of
“The FDA acceptance of our NDA for review, is an important milestone for
Xeris. If approved, the Xeris glucagon rescue pen would be the first
ready-to-use, liquid-stable glucagon in an auto-injector to treat severe
hypoglycemia. Compared to the current glucagon rescue option for people
with diabetes who are at risk for severe hypoglycemia, the Xeris
glucagon rescue pen would eliminate the need for reconstitution and
dramatically simplify the preparation and administration process,” said
The 505(b)2 NDA is based on positive results from multiple Phase 3
clinical trials of the efficacy, safety, and utility of the Xeris
glucagon rescue pen auto-injector in treating severe hypoglycemia when
compared with currently marketed glucagon emergency kits among adults,
children and adolescents with type 1 diabetes (NCT02656069, NCT03091673,
NCT03439072). Key study results
illustrating the efficacy and tolerability of the glucagon rescue pen
for both adults and children with diabetes were presented during the
78th Scientific Sessions of the
In addition, positive data from Human Factors usability and reliability
studies demonstrating the functional efficacy of the Xeris glucagon
rescue pen supported the NDA submission. The results of one of these
studies were presented during the
About Severe Hypoglycemia
Glucagon is the standard of care for treating severe hypoglycemia.
According to the
Hypoglycemic events of any severity are a daily concern for people with diabetes. Mild or moderate hypoglycemia can occur multiple times a month. Severe hypoglycemia is characterized by severe cognitive impairment, requiring external assistance for recovery, and can be extremely frightening for patients and caregivers. Severe hypoglycemia can result in cardiovascular disease, seizure, coma, and, if left untreated, death. These severe hypoglycemic events can occur multiple times a year. Such events require emergency assistance from another person or caregiver such as a family member, friend, or co-worker.
Xeris is a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use, room-temperature stable injectable and infusible drug formulations. The Company’s proprietary XeriSol™ and XeriJect™ formulation technologies are being evaluated for the subcutaneous (SC) and intramuscular (IM) delivery of highly-concentrated, non-aqueous, ready-to-use formulations of peptides, small molecules, proteins, and antibodies using commercially available syringes, auto-injectors, multi-dose pens, and infusion pumps. XeriSol™ and XeriJect™ have the potential to offer distinct advantages over existing formulations of marketed and development-stage products, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. These attributes may lead to products that are easier to use by patients, caregivers, and health practitioners and reduce costs for payers and the healthcare system. Further information about Xeris can be found at www.xerispharma.com.
Any statements in this press release about future expectations, plans
and prospects for
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